Edward Capovila
PFD Report
All Responded
Ref: 2022-0125
All 1 response received
· Deadline: 20 Jun 2022
Response Status
Responses
1 of 1
56-Day Deadline
20 Jun 2022
All responses received
About PFD responses
Organisations named in PFD reports must respond within 56 days explaining what actions they are taking.
Source: Courts and Tribunals Judiciary
Coroner’s Concerns
The evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths will occur unless action is taken. As indicated above, I was told that there is relatively little information available about the more unusual ways in which fentanyl can be misused or abused. Given the potential for fentanyl to be misused, as evidenced in Eddy’s inquest, I have concern that further deaths may occur in future if action is not taken.
Responses
The MHRA previously issued drug safety bulletins, undertook a review of opioid benefits/risks, updated product information and patient leaflets with addiction warnings, and highlighted this case to the Advisory Council on the Misuse of Drugs. Product information for all opioid licences is currently being updated to clearly state warnings about concomitant administration of benzodiazepines to ensure consistency.
AI summary
View full response
Dear Miss Gomersal,
Report to Prevent Future deaths - Edward Jorge Capovila
I am writing in response to the Regulation 28 Report concerning the tragic death of Mr Edward Capovila from overdose, likely from the inhalation of from prescribed patches.
It may be helpful to first outline the role of the MHRA, which is to monitor the safety of all medicines to ensure that up-to-date information on the benefits and risks of a medicine is available for healthcare professionals and patients. The authorised Summary of Product Characteristics (SmPC) for a medicine provides information for healthcare professionals about the medicine, including warnings and precautions of use in higher risk situations. The same information is provided to patients in a patient information leaflet, which is written in language that can be understood by the lay person and accompanies each medicine.
The MHRA became aware that if a patch is exposed to heat, it will increase the speed at which the fentanyl is absorbed into the body and therefore the patient is likely to be exposed to a higher initial dose than prescribed. In December 2014, the MHRA issued a drug safety bulletin1 warning healthcare professionals and patients of the risk of overdose and death with exposure of the patch to increased heat including the instruction that the patch should not be cut.
In 2019 the MHRA undertook a review of the benefits and risks for all medicines in the treatment of non-cancer pain and risks associated with dependence and addiction and sought the advice of an Expert Working Group of the Commission on Human Medicines, the MHRA’s advisory body. The Expert Working Group considered the benefit-risk profile of
-containing medicines and made recommendations for regulatory action to better support appropriate use of prescription including , with educational initiatives to increase the awareness of both patients and healthcare professionals of the risks of dependence, addiction, tolerance, withdrawal reactions, and risks of neonatal abstinence syndrome during pregnancy.
Following this review, in April 2019, warnings were added to the packaging of all to highlight that the medicine contains an opioid and the risk of addiction. This information was relayed to the public through several media outlets including the Guardian2 and BBC news3. In 2020, additional
1
Miss Kirsty Gomersal Area Coroner for the County of Cumbria By email:
Reference: CSC 97973
20th June 2022
warnings about the risk of addiction were included in the Summary of Product Characteristics for healthcare professionals and in the patient information leaflets. Further to this action, an article was published in the MHRA’s drug safety bulletin, Drug Safety Update (DSU) on 23 September 20204 highlighting the risk of addiction with containing medicines and the potential for overdose which could be fatal. An additional patient leaflet that is linked to the DSU article was recently updated in August 2021 following user-testing to ensure that patients understood the messages.
We are aware that fentanyl is available illicitly in several different forms. The MHRA works closely with other regulators and has highlighted this case to the Advisory Council on the Misuse of Drugs (ACMD). The ACMD undertook a review in 2020 on the misuse of patches and
analogues. The ACMD found that poison centre telephone enquiries of the misuse of patches is uncommon and prescribing had decreased between 2016 and 20185.
We note that Mr Capovila was also prescribed ). A warning is included within the product information for of a high risk of respiratory depression and an increased risk of opioid-related death when taken concomitantly with an
. A similar warning is included within the product information for opioids when used concomitantly with any central nervous system (CNS) depressant or sedative, like .
The product information for all licences is currently being updated to ensure that the warning of concomitant administration of as further examples of CNS depressants is clearly stated with the risk of coma or death. This action is being taken to ensure that all relevant product information is consistent.
We continue to monitor the benefits and risks of opioid containing medicines and will take further prompt regulatory action when required.
Report to Prevent Future deaths - Edward Jorge Capovila
I am writing in response to the Regulation 28 Report concerning the tragic death of Mr Edward Capovila from overdose, likely from the inhalation of from prescribed patches.
It may be helpful to first outline the role of the MHRA, which is to monitor the safety of all medicines to ensure that up-to-date information on the benefits and risks of a medicine is available for healthcare professionals and patients. The authorised Summary of Product Characteristics (SmPC) for a medicine provides information for healthcare professionals about the medicine, including warnings and precautions of use in higher risk situations. The same information is provided to patients in a patient information leaflet, which is written in language that can be understood by the lay person and accompanies each medicine.
The MHRA became aware that if a patch is exposed to heat, it will increase the speed at which the fentanyl is absorbed into the body and therefore the patient is likely to be exposed to a higher initial dose than prescribed. In December 2014, the MHRA issued a drug safety bulletin1 warning healthcare professionals and patients of the risk of overdose and death with exposure of the patch to increased heat including the instruction that the patch should not be cut.
In 2019 the MHRA undertook a review of the benefits and risks for all medicines in the treatment of non-cancer pain and risks associated with dependence and addiction and sought the advice of an Expert Working Group of the Commission on Human Medicines, the MHRA’s advisory body. The Expert Working Group considered the benefit-risk profile of
-containing medicines and made recommendations for regulatory action to better support appropriate use of prescription including , with educational initiatives to increase the awareness of both patients and healthcare professionals of the risks of dependence, addiction, tolerance, withdrawal reactions, and risks of neonatal abstinence syndrome during pregnancy.
Following this review, in April 2019, warnings were added to the packaging of all to highlight that the medicine contains an opioid and the risk of addiction. This information was relayed to the public through several media outlets including the Guardian2 and BBC news3. In 2020, additional
1
Miss Kirsty Gomersal Area Coroner for the County of Cumbria By email:
Reference: CSC 97973
20th June 2022
warnings about the risk of addiction were included in the Summary of Product Characteristics for healthcare professionals and in the patient information leaflets. Further to this action, an article was published in the MHRA’s drug safety bulletin, Drug Safety Update (DSU) on 23 September 20204 highlighting the risk of addiction with containing medicines and the potential for overdose which could be fatal. An additional patient leaflet that is linked to the DSU article was recently updated in August 2021 following user-testing to ensure that patients understood the messages.
We are aware that fentanyl is available illicitly in several different forms. The MHRA works closely with other regulators and has highlighted this case to the Advisory Council on the Misuse of Drugs (ACMD). The ACMD undertook a review in 2020 on the misuse of patches and
analogues. The ACMD found that poison centre telephone enquiries of the misuse of patches is uncommon and prescribing had decreased between 2016 and 20185.
We note that Mr Capovila was also prescribed ). A warning is included within the product information for of a high risk of respiratory depression and an increased risk of opioid-related death when taken concomitantly with an
. A similar warning is included within the product information for opioids when used concomitantly with any central nervous system (CNS) depressant or sedative, like .
The product information for all licences is currently being updated to ensure that the warning of concomitant administration of as further examples of CNS depressants is clearly stated with the risk of coma or death. This action is being taken to ensure that all relevant product information is consistent.
We continue to monitor the benefits and risks of opioid containing medicines and will take further prompt regulatory action when required.
Report Sections
Investigation and Inquest
On 3 November 2020, Dr Nicholas Shaw (Assistant Coroner) commenced an investigation into the death of Edward Jorge CAPOVILA who was known as Eddy. Eddy’s inquest was opened on 15 March 2021 and concluded on 22 April 2022 following a two-day hearing before me. The medical cause of Eddy’s death was: 1a Multi-drug toxicity II Hepatic steatosis The determination was: Mr Edward Jorge Capovila (who was known as Eddy) died on 30 October 2020 at in Barrow-in-Furness as the result of the combined toxic effect of prescribed medication. In administering that medication, Eddy did not intend to harm himself or take his own life. Eddy was prescribed nitrazepam, pregabalin and fentanyl (as transdermal patches). Nitrazepam metabolite was present in post-mortem blood but it could not be determined if levels were therapeutic or excessive. Pregabalin was found at 3.6 mg/l which is consistent with therapeutic use. Fentanyl was present at 6.3 μg/l. These medications are central nervous system depressants which have an additive effect when used together. No fentanyl patches were found on Eddy's body. On balance, Eddy has administered fentanyl by heating and inhaling it. The conclusion of the inquest was: Death by misadventure.
Circumstances of the Death
I found that, on the balance of probabilities, Eddy had administered himself fentanyl by heating and inhaling it. It could not be determined how many patches Eddy had used as none were located on his body or in the house.
Eddy had chronic pain which required strong painkilling medication i.e. fentanyl. He had also been known to use drugs and had demonstrated drug seeking behaviour.
The inquest heard that the amount of fentanyl in a transdermal patch needs to be higher than that taken transdermally. For instance, the patches prescribed to Eddy required 2.7mg fentanyl to release 37.5 μg/hr hour over 72 hours. However, each patch contains 6.3mg fentanyl to maintain the concentration gradient. Even a “used” fentanyl patch therefore contains significant amounts of fentanyl that could be misused.
Evidence was heard about the steps taken following Eddy’s death. Part of the wider learning was to increase awareness (at local Trust level) of how fentanyl can be abused / misused other than by the application of excess fentanyl patches. The inquest heard that there is relatively little information available about the other ways in which fentanyl can be abused.
It is known that heating a fentanyl patch can increase the rate at which fentanyl is dispensed; hence the warnings not to wear patches in a hot bath, for example. Applying a direct heat source onto a patch can release fentanyl so that it can be abused – such as by inhalation (as in Eddy’s case). I was told of other means by which released fentanyl can be abused. Given the amounts of fentanyl that remain even in a used patch, a potentially lethal dose of fentanyl can be released for misuse.
Eddy had chronic pain which required strong painkilling medication i.e. fentanyl. He had also been known to use drugs and had demonstrated drug seeking behaviour.
The inquest heard that the amount of fentanyl in a transdermal patch needs to be higher than that taken transdermally. For instance, the patches prescribed to Eddy required 2.7mg fentanyl to release 37.5 μg/hr hour over 72 hours. However, each patch contains 6.3mg fentanyl to maintain the concentration gradient. Even a “used” fentanyl patch therefore contains significant amounts of fentanyl that could be misused.
Evidence was heard about the steps taken following Eddy’s death. Part of the wider learning was to increase awareness (at local Trust level) of how fentanyl can be abused / misused other than by the application of excess fentanyl patches. The inquest heard that there is relatively little information available about the other ways in which fentanyl can be abused.
It is known that heating a fentanyl patch can increase the rate at which fentanyl is dispensed; hence the warnings not to wear patches in a hot bath, for example. Applying a direct heat source onto a patch can release fentanyl so that it can be abused – such as by inhalation (as in Eddy’s case). I was told of other means by which released fentanyl can be abused. Given the amounts of fentanyl that remain even in a used patch, a potentially lethal dose of fentanyl can be released for misuse.
Copies Sent To
Bridgegate Medical Centre, Eddy’s GP, for information
Similar PFD Reports
Reports sharing organisations, categories, or themes with this PFD
Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.